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Alefacept in Moderate to Severe Atopic Dermatitis
NCT00832585Phase 4
Key facts
- Status
- Completed
- Start
- Jan 2008
- Primary completion
- Sep 2009
- Countries
- 1
- Sponsor
- Rush University Medical Center
- Modality
- Fc-Fusion Proteins
- Drugs
- alefacept
- Conditions
- atopic dermatitis (AD)
01
Overview
Phase 4, open-label, single-arm trial of alefacept in atopic dermatitis (AD), sponsored by Rush University Medical Center. Primary endpoint: Change in Eczema Area Severity Index Score at 16 weeks. Started Jan 2008; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Alefacept
Alefacept 15mg IM every week for 12 weeks
03
Who it enrols
Adults with moderate to severe atopic dermatitis (PGA 3-4) uncontrolled by topical therapies, excluding those with active infections, malignancy history, or significant lab abnormalities.
04
Endpoints
Primary
Change in Eczema Area Severity Index Score
Secondary
Change in Physician Global Assessment Score
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